Heart presentation device and method

ABSTRACT

A medical instrument for positioning an internal organ during surgical and diagnostic procedures is provided. In one embodiment, the medical instrument includes a body having a tissue grasping element and an actuating member effective to move the tissue grasping element between an open position and a closed position. The body also includes a flexible member which has a portion secured to the body and at least one free end. In use, the tissue grasping element grasps or penetrates a portion of the tissue on or near the body organ. Tension can then be applied to the flexible member to reposition and secure the body organ.

FIELD OF THE INVENTION

[0001] The present invention relates to methods and apparatuses forpositioning a body organ, and more particularly, to medical instrumentsthat assist in manipulating and suspending a patient's heart at adesired position during diagnostic and surgical procedures.

BACKGROUND OF THE INVENTION

[0002] Coronary artery disease results in a narrowing of the coronaryarteries, which are the blood vessels that supply the heart with oxygenand nutrients. There are two main coronary arteries: the left maincoronary artery, which supplies blood to the left ventricle, and theright main coronary artery, which supplies blood to the right ventricleas well as the posterior surface of the left ventricle. These maincoronary arteries give rise to several branches that extend into theheart muscle (myocardium), bringing vital nutrients to each muscle cell.The heart relies on these nutrients as it works constantly to pump bloodthrough the body. Narrowing of the coronary arteries reduces blood flowto the myocardium and, if untreated, can damage and/or destroy the heartmuscle.

[0003] In some cases, coronary artery disease may be treated by the useof drugs and/or by modifications in behavior and diet. For certainpatients, however, a coronary artery bypass graft (CABG) procedure isthe preferred form of treatment to restore adequate blood flow. A CABGprocedure improves the flow of blood and ensures that the heart muscleis receiving an adequate supply of oxygen-rich blood.

[0004] In a CABG procedure, a blocked section of the artery is literally“bypassed” by attaching a healthy segment of blood vessel downstreamfrom the diseased or blocked area. During surgery, an incision is madein the patient's chest and the sternum is divided to allow access to thepericardial sac, which envelops and protects the heart.

[0005] Some CABG procedures can be performed with a beating heart, whileothers require that the heart be arrested, usually by administering achemical solution, called cardioplegia, that temporarily paralyzes theheart muscle fibers. In procedures where the heart is arrested,circulation is maintained by a heart-lung machine.

[0006] During the procedure, manual manipulation and repositioning ofthe heart is usually necessary to access the blocked arteries. Theposterior descending artery, for example, lies on the posterior surfaceof the heart. The surgeon or a surgical assistant is therefore requiredto lift and rotate the heart to expose the artery. Often, a surgeon useshis or her own hands to position the heart. However, it is difficult tomaintain the heart in a secure and proper position by such techniques.In addition, direct manual contact with the heart may impaircirculation, leading to reductions in cardiac output and blood pressure.Care must be exercised to avoid trauma to the heart or pericardial sacto avoid the formation of excessive adhesions.

[0007] In order to overcome these problems, devices such as slings andballoons have been developed to help position and/or stabilize theheart. A balloon, for example, is placed underneath the heart and isthereafter inflated to lift the heart into a desired position. A sling,on the other hand, is a fabric or plastic based device that is placedaround the heart in the manner of a hammock. The heart can then bepositioned by moving the sling.

[0008] While attempts have been made to support the heart during a CABGsurgery, the resulting devices and techniques have several drawbacksthat have hindered their acceptance in the art. For example, slings madeof net or fabric tend to interfere with access to the surgical target.Moreover, net slings require special techniques or procedures to removethe net from the surgical target area. Where a balloon is employed, theheart is freely slidable on the balloon, and not necessarily securelypositioned, thus posing a risk of damage during the surgical procedure.Moreover, if a balloon is over-inflated, it can exert excess pressure onthe heart, potentially causing damage to the heart.

[0009] In addition to the aforementioned problems, the recent trend inmoving toward less invasive procedures makes placement of a sling orinflatable balloon nearly impossible. A minimally invasive cardiacsurgery (MICS) procedure is a new technique which, compared withstandard cardiac procedures, causes less pain, speeds recovery, anddelivers identical results at less cost.

[0010] MICS procedures are usually performed on the beating heart,thereby eliminating the expense and risk of stopping the heart and thenecessity of a heart-lung bypass machine. The procedure is performed bymaking an incision in the chest (thorocotomy). A heart stabilizer can beused to restrict movement of the heart within the limited surgicalfield.

[0011] Since the surgeon is operating on a beating heart, both movementand blood can cause a sling or balloon to displace during surgery.Moreover, the surgeon's ability to access and manipulate the heart ishampered since the incision used to access the thoracic cavity is muchsmaller. As a result, the limited surgical field makes placement of anytype of inflatable balloon or sling around the heart very difficult.

[0012] Surgeons have also employed retraction sutures and retractiontapes to lift and secure the heart during surgical procedures. In onetechnique a number of retraction sutures (e.g., three) are placed deepwithin the pericardium and then tensioned to lift the heart. In anothertechnique, retraction tapes, which are usually thick, porous straps, areplaced strategically around the heart. The tapes are then graduallyretracted to reposition the heart and expose the target artery.Typically, two pairs of retraction tapes are employed. The first pair ispassed through the transverse sinus, and the second pair is passedbeneath the inferior vena cava. One end of each tape is fixed to astationary support and the other end of each tape is kept free. The freeends can then be retracted to position the heart. Once the heart is inthe desired position, the free ends of the tapes can be secured to thesupport.

[0013] The use of retraction sutures and retraction tapes has somedrawbacks in that it is difficult and time consuming to place thesedevices properly while avoiding risk of damage to the heart.

[0014] For example, when sutures are used, the tip of the suture needlemust be placed along the pericardium, and then rotated to penetratethrough the tissue. Unpredictable motion of the epicardial surfaceduring needle placement may cause laceration of the heart or puncture ofa coronary artery. A high degree of skill is also required to grasp theproper amount of tissue. If an insufficient amount of tissue is engaged,the suture may tear through the tissue and fail. Conversely, if too muchtissue is engaged, the suture may penetrate and possibly damage anunderlying organ, such as the lung.

[0015] The proper placement of retraction tapes is made difficult due tothe limited surgical field and reduced field of vision. Moreover, theprocedure can be time consuming and risky since a pair of retractiontapes needs to be placed through the transverse sinus. Traumaticstressing of the transverse sinus, or excessive destruction of thetissue, can lead to stenosis, further compromising the patient's health.Further, the placement of retraction tapes directly around the heart canlead to a significant drop in blood pressure.

[0016] Accordingly, there is a need for an organ positioning andmanipulating device which can be easily, quickly, and safely employed topresent and expose target surgical tissue.

SUMMARY OF THE INVENTION

[0017] The present invention provides a medical instrument forpositioning an internal organ during surgical and diagnostic procedures.The instrument is useful in that it can be safely and effectivelyutilized during surgical procedures to reposition a body organtemporarily. This instrument enables the organ of interest or tissueadjacent to the organ of interest to be securely grasped, and it alsoenables manipulation and repositioning of the organ.

[0018] In one embodiment, the medical instrument includes a body havinga tissue grasping element and an actuating member effective to move thetissue grasping element between an open position and a closed position.The instrument also includes a flexible member which has at least onefree end and another end secured to the body. In use, the tissuegrasping element grasps or penetrates a portion of the tissue on or nearthe body organ. Tension can then be applied to the flexible member toreposition and secure the body organ.

[0019] In one embodiment of the invention, the tissue grasping elementincludes first and second opposed tissue penetrating claws, and theactuating member includes opposed first and second actuating members.The tissue penetrating claws are opened by bringing the first and secondactuating members in contact with each other.

[0020] In a further embodiment, the medical instrument includes ahousing disposed on the body, and a removable applicator sleeve slidablydisposed on the housing and adapted to selectively engage the actuatingmember. The applicator sleeve is movable between a first, proximalposition in which the applicator sleeve is free from contact with theactuating member, and a second, distal position in which the applicatorsleeve is able to engage the actuating member and thereby move thetissue grasping element between an open position and a closed position.

[0021] In another embodiment, the medical instrument includes a handlemated to the free end of the flexible member. The actuating member canbe in the form of a wire that communicates between a portion of thehandle and the tissue grasping element. A lever movably disposed on thehandle and attached to the wire is effective to move the wire andthereby move the tissue grasping element between the open and closedpositions. The medical instrument can optionally include a lockingelement, such as a latch disposed on the handle and mated to the leverfor releasably locking the tissue grasping element in one of the open orclosed positions.

[0022] In yet another embodiment, the medical instrument includes anelongate, rigid body having a proximal end and a distal end. The tissuegrasping element extends from the distal end of the body and is mated toa cable slidably disposed on the body and connected to a lever. Movementof the lever is effective to move the tissue grasping element betweenthe open and closed positions.

[0023] The present invention also provides a method for positioning abody organ utilizing a medical instrument according to the presentinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention will be more fully understood from the followingdetailed description taken in conjunction with the accompanyingdrawings, in which like reference numerals designate like partsthroughout the various figures, and wherein:

[0025]FIG. 1 is a perspective view of a medical instrument according toone embodiment of the present invention;

[0026]FIG. 2A is a perspective view of the medical instrument of FIG. 1in a closed position and including a positioning tool according to thepresent invention;

[0027]FIG. 2B is a perspective view of the medical instrument of FIG. 1in an open position, actuated by the positioning tool of FIG. 2A;

[0028]FIG. 2C is a perspective view of the medical instrument of FIG. 1in a closed position and grasping a portion of tissue;

[0029]FIG. 3 is a perspective view of a further embodiment of themedical instrument of FIG. 1 including a housing and an applicatorsleeve according to another embodiment of the present invention;

[0030]FIG. 4A is a perspective view of a medical instrument similar tothat of FIG. 3 in a closed position;

[0031]FIG. 4B is a perspective view of the medical instrument of FIG. 4Ain an open position, actuated by an applicator sleeve;

[0032]FIG. 4C is a perspective view of the medical instrument of FIG. 4Ain a closed position and grasping a portion of tissue;

[0033]FIG. 5 is a perspective view of a medical instrument according toyet another embodiment of the present invention;

[0034]FIG. 6 is a diagram illustrating the handle of the medicalinstrument of FIG. 5;

[0035]FIG. 7A is a diagram illustrating the medical instrument of FIG. 5in an open position;

[0036]FIG. 7B is a diagram illustrating the medical instrument of FIG. 5in a closed position; and

[0037]FIG. 8 is a perspective view of a medical instrument according toanother embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0038] The present invention relates to a medical instrument forassisting in manipulating and suspending a body organ at a desiredposition during diagnostic and/or surgical procedures. The medicalinstrument of the present invention is particularly useful forpositioning a patient's heart during a coronary artery bypass procedure.The instrument can be easily, quickly, and safely employed to presentand expose target surgical tissue.

[0039] In general, the medical instrument according to the presentinvention includes a body having a tissue grasping element, an actuatingmember effective to move the tissue grasping element between an openposition and a closed position, and a flexible member. In use, theactuating member is manipulated to cause the tissue grasping element topenetrate or grasp a portion of the tissue on or near the body organ ofinterest. The flexible member can then be tensioned and retracted toposition the body organ as desired. Once the body organ is in thedesired position, a free end of the flexible member can be secured to asupport (not shown) to maintain the body organ in a desired position.

[0040]FIG. 1 illustrates one embodiment of a medical instrument 10according to the present invention. In general, the medical instrumentincludes a body 13, a tissue grasping element 14, and an actuatingmember 16. The body 13 mates the tissue grasping element 14 with theactuating member 16, and can have any shape and can be any type ofconnector, or similar device. In one embodiment, the body is a rivet orscrew which forms a pivot point between the tissue grasping element 14and the actuating member 16. Alternatively, the body 13 can be aseparate element disposed around pivot point 13 to join the tissuegrasping element 14 and the actuating member 16, or it can be formedintegrally with the tissue grasping element 14 and the actuating member16.

[0041] The tissue grasping element 14 extends distally 26 from the body13 and includes first and second opposed tissue penetrating claws 14 a,14 b. The tissue grasping element 14 can be removably appended to thebody 13 to optionally allow the tissue grasping element 14 to bereplaced after use, or, alternatively, the tissue grasping element 14can be integral with the body 13. The tissue penetrating claws 14 a, 14b have a semi-circular shape and include two opposed tissue piercingends 11 a, 11 b which meet in the closed position to essentially form acircle or oval, as shown. In use, the tissue penetrating claws 14 a, 14b are movable between a closed position (shown in FIGS. 1, 2A, and 2C)and an open position (shown in FIG. 2B). While each tissue penetratingclaw 14 a, 14 b is shown as having a generally semi-circular shape, aperson having ordinary skill in the art will appreciate that the tissuepenetrating claws 14 a, 14 b can have any shape, such as square, oval,rectangular, etc. A person having ordinary skill in the art willappreciate that the term “tissue penetrating claw” as used herein isintended to include any element, having any shape or size, that iseffective to penetrate tissue.

[0042] The first and second actuating members 16 a, 16 b extendproximally 28 from the body 13 and are opposed to the tissue penetratingclaws 14 a, 14 b. The actuating members 16 a, 16 b are effective to movethe tissue penetrating claws 14 a, 14 b between the open and closedpositions, as shown in FIGS. 2A-2C. The actuating members 16 a, 16 b canbe elongated handles or similar structures formed integrally with, ormated to, the tissue penetrating claws 14 a, 14 b. Alternatively, theactuating members 16 a, 16 b can extend into, attach to, or be disposedwithin the body 13 to mate directly or indirectly with the tissuegrasping element 14. In an exemplary embodiment, actuating member 16 ais integral with tissue penetrating claw 14 b, and actuating member 16 bis integral with tissue penetrating claw 14 a. The two integral memberscan be connected at the pivot point formed by the body 13.

[0043] The medical instrument 10 can optionally include a biasingelement 17 to maintain the tissue penetrating claws 14 a, 14 b in one ofthe open or closed positions. The biasing element 17 can be a spring, orsimilar device, mated to the actuating members 16 a, 16 b or to thetissue penetrating claws 14 a, 14 b. Alternatively, the biasing element17 can be mated to, or formed integrally with, the body 13.

[0044] In use, the biasing element 17 applies a force to maintain thetissue penetrating claws 14 a, 14 b in one of the open or closedpositions. The force of the biasing element 17 can be overcome bygrasping the actuating members 16 a, 16 b causing the members to contacteach other and thereby move the tissue penetrating claws 14 a, 14 b fromthe closed position, as shown in FIG. 2A, to the open position, as shownin FIG. 2B.

[0045] As shown in FIGS. 2A-2C, an instrument 15, such as forceps, maybe used to apply a force to the actuating members 16 a, 16 b sufficientto overcome the biasing force. Once the tissue penetrating claws 14 a,14 b are in the open position, the instrument 10 can be manipulated andpositioned to allow to claws 14 a, 14 b to penetrate tissue 60. Uponrelease of the actuating members 16 a, 16 b, the biasing element 17causes the tissue penetrating claws 14 a, 14 b to return to the closedposition to grasp a desired portion of tissue, as shown in FIG. 2C.

[0046] Once the tissue is firmly grasped by the medical instrument 10,the flexible member 18 can be used to retract and position the bodyorgan. The flexible member 18 includes a proximal, free end 19 that isselectively fastenable to a support (not shown), and a distal end matedto the body, or any other part of the medical instrument 10. A rivet,screw, snap, buckle, adhesive, or similar attachment member can be usedto secure the flexible member 18 to the body 13. Similarly, the free end19 of the flexible member 18 can include a snap, buckle, hook and eyeclosure, or similar device for tying or securing the flexible member 18to a support. The length of the flexible member should be sufficientenough to allow the flexible member 18 to extend from the body organ tothe support or some other position outside the body. In use, tension isapplied to the flexible member 18 to retract and position the body organ(or tissue). The free end 19 of the flexible member 18 can then besecured to a support (not shown) to maintain the organ (or tissue) in adesired position.

[0047] A further embodiment of medical instrument 10 is shown in FIG. 3,which illustrates a medical instrument 20 having a housing or body 12disposed around medical instrument 10, a flexible member 18′, and aremovable applicator sleeve 22 slidably disposed on the housing 12 andthe flexible member 18′. The body 13 and tissue grasping element 14 ofmedical instrument 10 are substantially the same as that discussed withrespect to FIG. 1. The actuating members 16 a, 16 b, however, each maybe essentially semi-circular to form a circle when the members 16 a, 16b are grasped and squeezed together.

[0048] The housing 12 of medical instrument 20 is generally elongate andincludes a first surface 53, a second surface (not shown) opposed to thefirst surface, and side surfaces 55 connecting the first and secondsurfaces. The first, second, and side surfaces 53, 55 define a cavityfor receiving medical instrument 10. The side surface 55 includes twoopposed proximal openings 81 a, 81 b from which the actuating members 16a, 16 b of medical instrument 10 extend, and two opposed distal openings82 a, 82 b from which the tissue penetrating claws 14 a, 14 b of medicalinstrument 10 extend. The proximal openings 81 a, 81 b should have asize substantially the same as the length of the members 16 a, 16 b soas to allow a portion of the actuating members 16 a, 16 b to extendtherefrom. The distal openings 82 a, 82 b, on the other hand, should beof a sufficient size to allow the tissue penetrating claws 14 a, 14 b tomove between th en and closed positions, respectively. Preferably, thedistal openings each have a length of between about 3 to 8 mm. The sizeof the housing or body 12 should be sufficient to hold the medicalinstrument 10 therein, and should have a width less than the width ofthe actuating members 16 a, 16 b to allow the actuating members 16 a, 16b to protrude there from.

[0049] One of ordinary skill in the art will appreciate that actuatingmembers 16 a, 16 b need not extend from openings 81 a, 81 b. Instead, astructure, such as a button (not shown) may extend from each opening.Force applied to the buttons will be transferred to the actuatingmembers 16 a, 16 b to cause opening or closing of the tissue penetratingclaws 14 a, 14 b.

[0050] Medical instrument 10 can be mated to, or merely disposed within,the housing or body 12. For example, the actuating members 16 a, 16 band the tissue grasping element 14 can be molded into the housing 12, orthey can be pivotably attached to the housing 12 with a securing device,such as with the body 13, which may be in the form of a rivet or screwas described above with respect to FIG. 1. Thus, the body 13 can extendthrough the first surface of the housing 53, the tissue grasping element14 and actuating member 16, and the second surface of the housing. Arivet, screw, rod, or similar attachment device can be used secure theactuating members 16 a, 16 b and the tissue grasping element 14 to thehousing 12.

[0051] The flexible member 18′ is similar in placement and operation tothat described with respect to FIG. 1, however, the distal end (notshown) of flexible member 18′ can be mated to the housing 12, ratherthan the body 13. The proximal end 19′ of the flexible member 18′, aswell as the proximal end 28 of the applicator sleeve 22, can have ashape and size adapted to provide an improved gripping surface, and toallow the medical instrument 30 to be secured to a support (not shown).In use, the flexible member 18′ is disposed within the applicator sleeve22 to allow the applicator sleeve 22 to slidably move with respect tothe housing 12.

[0052] The applicator sleeve 22 has a substantially rigid elongate bodyand it is effective to depress the actuating members 16 a, 16 b, andthereby move the tissue grasping element 14 to the open position. Theapplicator sleeve 22 includes an inner cavity which can be dimensionedto fit slidably over the housing 12 and the flexible member 18′. Thesides of the applicator sleeve 22 should conform to the sides of thehousing 12, such that movement of the applicator sleeve 22 over thehousing 12 will depress the actuating members 16 a, 16 b. The proximalend 28 of the applicator sleeve 22 can include one or more openings 24to enable a portion of the flexible member 18′ to be grasped withrespect to the sleeve 22, thereby preventing movement of the applicatorsleeve 22. The length and width of the applicator sleeve 22 can varydepending on the size of the housing 12. In one embodiment, theapplicator sleeve preferably has a length of 15 cm and a width of 15 mm.

[0053] As shown in FIGS. 4A-4C, the applicator sleeve 22 is movablebetween a first, proximal position 28 (shown in FIG. 4A), and a seconddistal position 26 (shown in FIG. 4B). In the first, proximal position28, the applicator sleeve 22 is free from contact with the actuatingmembers 16 a, 16 b. In the second, distal position 26, on the otherhand, the applicator sleeve 22 is able to engage the actuating members16 a, 16 b causing them to move together, thus moving the tissuepenetrating claws 14 a, 14 b from the closed (shown in FIG. 4A) to theopen position (shown in FIG. 4B). Once the sleeve 22 is returned to theproximal position 28 (shown in FIG. 4C), the claws 14 a, 14 b closetogether and engage the tissue 50.

[0054] In one embodiment, the flexible member 18′ is pulled through theinner lumen of the applicator sleeve 22 and held with tension to securethe applicator sleeve 22 onto the housing 13. The applicator sleeve 22is then used to manipulate the body and cause the tissue graspingelement 40 to grasp or penetrate tissue. The flexible member 18′ canthen be released and the applicator sleeve 22 slid off of the body 12.Tension can then be applied to flexible member 18′ to retract andposition the body organ (or tissue). The free end 19′ of the flexiblemember 18′ can then be secured to a support (not shown) to maintain theorgan (or tissue) in a desired position

[0055] Another embodiment of a medical instrument 30 is illustrated inFIGS. 5-7B and includes a body 37, a tissue grasping element 31, ahandle 32, a flexible member 39 disposed between the body 37 and thehandle 32, and an actuating system. The body 37 can have any shape, butis preferably substantially disk-shaped and includes an inner cavity orlumen 35 for receiving the tissue grasping element 31. The cavity 35should have a shape that allows the tissue grasping element to slidablymove therein, but yet prevents wobbling of the tissue grasping elementduring use. The distal end 26 of the body 37 can include an indented orconcave portion 83 and an opening 45 from which the tissue graspingelement 31 extends. The opening 45 can have any shape, and should have asize sufficient to allow the tissue grasping element 31 to protrudethere from. When the tissue grasping element is actuated, and therebyextended from the opening 45, the concave portion 83 allows the tissuegrasping element 31 to extend beyond the distal end 26 of the body 37and grasp a desired portion of tissue. The body 37 can also include aproximal opening 47 for receiving and/or mating with the flexibleelongate member 39 and the actuating member 41. The body 37 can be madefrom the same materials as housing 12 discussed with respect to FIG. 3.

[0056] The tissue grasping element 31 is disposed within the cavity 35of the body 37, and is slidably movable between a closed position, inwhich a portion of the tissue grasping element 31 extends from theopening 45 in the distal end 26 of the body 37, and an open position, inwhich the tissue grasping element 31 is fully disposed within the body(not shown). The tissue grasping element can be substantiallysemi-circular and can be made from a needle, or similar tissuepenetrating member. The materials used to construct the tissue graspingelement can be the same or similar materials as tissue grasping element14, discussed with respect to FIG. 1.

[0057] The flexible member 39 is effective to mate the body 37 to thehandle 32, and it includes a distal end mated to or disposed within thebody 37 at opening 47, and a proximal end mated to the handle 32. Theflexible member 39 is similar to flexible members 18 and 18′ describedwith respect to FIGS. 1 and 3, and should have a length sufficient toallow the handle 32 to be positioned at a location outside of the body.In an exemplary embodiment, a path or lumen is formed on or within theflexible member for receiving and/or guiding a wire 41, which is part ofthe actuating system. The flexible member 39 can be semi-rigid, oralternatively, the medical instrument 30 can optionally include a secondflexible member (not shown) for providing added rigidity to the flexiblemember 39, and for providing additional stability between the body 37and the handle 32. The distal end 26 of the second flexible member canbe removably disposed within the opening 47 of the body 37 to allow thesecond flexible member to be removed once the organ is positioned.

[0058] The actuating system used with medical instrument 30 includes arotatable member 33 disposed within the body 37, a lever 34 disposed onthe handle 32, and a wire 41 connecting the rotatable member 33 to thelever 34. The actuating system can also include a biasing element 43 formaintaining the tissue grasping element 31 in one of the open or closedpositions.

[0059] The rotatable member 33 is disposed with the cavity 35 of thebody 37 and is slidably movable along a groove or guide path defined bythe cavity 35. A first end 51 of the rotatable member 33 is mated to theproximal end 28 of the tissue grasping element 31, and a second end 49of the rotatable member 33 is mated to the wire 41, which extends alongthe flexible member 39 to the lever 34 on the handle 32. The rotatablemember can have any shape, and should be sized to fit within the cavity35. Movement of the actuating member 41 is effective to move therotatable member 33 and thereby move the tissue grasping element 31between the open and closed positions.

[0060] The wire 41 (or a similar element), disposed within or along theflexible member 39, is able to effect movement of the rotatable memberbetween the open and closed positions. The distal end 26 of the wire 41is mated to the rotatable member 33, and the proximal end 28 of the wireis mated to a lever 34 that is disposed within the handle 32. A rivet,screw, snap, adhesive, or similar attachment member can be used tosecure the wire 41 to the rotatable member 33 and the lever 34. In use,movement of the lever 34 is effective to move the wire 41, therebymoving the rotatable member 33 and the tissue grasping element 31between an open (retracted) position and closed (extended) position.

[0061] The handle 32, which is shown in more detail in FIG. 6, can beconstructed from any type of rigid or semi-rigid material having anyshape, such as rectangular, or cylindrical, and includes an inner cavityfor holding the lever 34, and optionally a locking mechanism 38 and abiasing element 43. One side (e.g., the top side) of the handle 32includes an opening that extends between the distal and proximal ends26, 28 of the handle 32 for receiving the lever 34. The opening shouldhave a length sufficient to allow the lever 34 to move proximally anddistally to fully open or close the tissue grasping element. The handle32 also includes a distal opening 91 for receiving the flexible member39 and the wire 41. The flexible member 39 can be removably disposedwithin opening 39, or it can be mated to the handle at or near opening39. Optionally, the handle 32 can include a proximal opening 36 forreceiving the locking mechanism, or latch 38, to lock the lever 34 in aproximal position (shown in FIG. 7B).

[0062] The lever 34 shown in FIG. 6 is disposed within the inner cavityof the handle 32 and includes a protruding portion 34′ for grasping andmoving the lever 34 in the proximal 28 and distal 26 directions. Thelever 34 can have a variety of different shapes, but should be sized toslidably fit within the opening in the top side of the handle 32. Theprotruding portion 34′ of the lever 34 should have a size and shapewhich allows a user to grasp and easily move the lever 34 along theopening in the handle 32.

[0063] The proximal end 28 of the lever can include a latch 38 forreleasably locking the lever 34 is the proximal position (shown in FIG.7B). The latch 38 can be attached to the proximal end 28 of the lever34, such that movement of the lever 34 is effective to move the latch38. When the lever 34 is in the distal position, as shown in FIG. 7A,the latch 38 is fully disposed within the handle 32. Conversely, whenthe lever 34 is moved to the proximal position, the latch 38 extends upinto the opening 36, as shown in FIG. 7B. Pressure exerted on the latch38 can be used to release the latch 38 from the locked, proximalposition.

[0064] Medical instrument 30 can optionally include a biasing member 43,e.g. a spring, mated to the lever 34 for biasing the lever 34 to thedistal 26 position, and thereby holding the tissue grasping element 31in one of the open or closed positions. The spring 17 can be disposedwithin the handle 32 and attached on one end to the handle 32 and on theother end to a portion of the lever 34. The biasing member provides aforce such that movement of the lever 34 in the proximal direction 28requires a force sufficient to overcome the force of the biasing member43. In an exemplary embodiment, the tissue grasping element 14 is biasedto the open position (shown in FIG. 7A), in which the tissue graspingelement 14 is fully disposed within the inner lumen of the body 37.

[0065] In use, the concave portion 83 of the body 37 is placed against abody organ (not shown), and the lever 34 is moved in the proximaldirection 28, thereby pulling the wire 41 and the rotatable member 33,and causing the tissue grasping element 31 to penetrate a desiredportion of tissue. Simultaneously, the latch 38 extends into opening 36to lock the lever 34 in the proximal position and the tissue graspingelement 31 in the closed (extended) position. The handle 32 can then betensioned and retracted to position the body organ. The weight of thehandle 32 can be used to lay the handle 34 at a position outside of thehuman body to maintain the body organ in the desired position. Where themedical instrument 30 includes a second flexible member, the distal end26 of the second flexible member can be removed from opening 47 in thebody 37 to allow flexible member 39 to bend. This features provides easeof placement of the handle at any location outside of the human body.

[0066]FIG. 8 illustrates another embodiment of a medical instrument 50including an elongate, rigid or semi-rigid body 52 which defines acavity for receiving a tissue grasping element 60. The body 52 includesa proximal end 28 having an opening or slit 56 for receiving a lever 58effective to move an actuating member 54, and an open distal end 26which is adapted to receive the tissue grasping element 60. The cavityof the body 52 can extend throughout the length of the body, or can beformed within the distal end 26 of the body. The outer periphery of thebody 52 includes a groove or lumen for receiving the actuating member54. In use, the body can act as a flexible elongate member forpositioning an organ, or alternatively, a flexible elongate member (notshown) similar to flexible elongate members 18, 18′ can extend from theproximal end of the medical instrument 50.

[0067] The tissue grasping element 60 is a substantially disk-shapedmember that includes a tissue piercing portion 42 extending from theopen distal end 26 of the body 52. In one embodiment, shown in FIG. 8,the tissue grasping element 60 is pivotably mated to the body 52 atpivot point 59 located substantially at the center of the diskshapedtissue grasping element 60. The actuating member, e.g. a cable or wire54 is attached to the tissue grasping element 60 at two opposed points44, 46. The points 44, 46 should be located at opposed points adjacentthe tissue piercing portion 42. In an alternative embodiment (notshown), the wire 54 can be attached to the tissue grasping element 60 ata single point 44 or 46. In use, movement of the wire 54 is effective torotate the tissue grasping element 60, thereby causing the tissuepiercing portion 42 to extend and retract the from the opening in thedistal end 26 of the body 52.

[0068] The wire 54 is slidably disposed on the body 52 along or withinthe groove or lumen around the peripheral edge of the body 52, and matesthe tissue grasping element 60 and the lever 58. The wire 54 can extendfrom one point 44 to the lever 58, and then connect to the tissuegrasping element 60 at opposed point 46. Alternatively, the wire 54 canbe attached to the tissue grasping element 60 at one point 44 or 46 andterminate at the lever 58.

[0069] The lever 58 is effective to apply a force to the wire 54 to movethe tissue grasping element 60 between the open and closed positions.The lever 58 can be any type of structure, such as a handle, whichslidably extends from the slit or opening 56 in the body. While thelever 58 is shown extending from slit 56 at the proximal end 28 of thebody 52, the lever 58 and the slit 56 can be positioned at any locationon the body 52.

[0070] The medical instrument 50 can optionally include a biasingelement, e.g. a spring 71, to bias the lever 58 to hold the tissuegrasping element 60 in one of the open or closed positions.Alternatively, the spring 71 can bias the tissue grasping element 60(not shown).

[0071] While FIG. 8 illustrates a pulley system for rotating the tissuegrasping element 60, a person having ordinary skill in the art willappreciate that other systems can be used to actuate the tissue graspingelement 60. By way of non-limiting example, a gear can be disposedwithin the body 52 for turning the tissue grasping element 60.

[0072] The body 13, 37, 52 of the medical instrument 10, 20, 30, 50according to the present invention can be formed from a medicallycompatible rigid or semi-rigid material. Suitable materials includeplastics, light weight metals or metal alloys, and composite materials.Preferably, the body 13, 37, 52 is made of a biocompatible material,such as, for example, titanium or a titanium alloy, or a variety ofrigid polymers known to be useful in medical devices. Similarly, incertain embodiments of the invention, other parts of the medicalinstrument 10, 20, 30, 50, such as the housing 12, applicator sleeve 22,handle 32, lever 34, 58, and rotatable member 33, can be made from thesame or similar material as the body 13, 37, 52.

[0073] The tissue grasping element 14, 31 60 can be made from a rigid orsemi-rigid material, such as plastic, light weight metal or metal alloy,or a composite material. Preferably, the tissue grasping element is madefrom stainless steel. Any standard size needle can be used to form thetissue grasping element 14. However, the tissue grasping element 14 ispreferably an SH½ circular needle, a CT2 needle, or a V-7 needle.

[0074] Structures from which the flexible member 18, 18′, 39 can be madeinclude straps, cords, sutures, and bands. A variety of suitablematerials can be used to form the flexible member 18, including anymaterial that is substantially inelastic and/or flexible. Alternatively,the flexible member 18, 18′, 39 can be made from an elastic material,such as latex or silicone.

[0075] In use, medical instrument 10, 20, 30, 50 is effective forpositioning any body organ, but is preferably used for positioning apatient's heart. The procedure involves positioning the body inproximity to the internal organ to be repositioned, and thenmanipulating the body so that the tissue grasping element grasps orpenetrates a desired portion of tissue. Tension can then be applied tothe flexible member to reposition and secure the body organ. Once theorgan is properly positioned, the free end of the flexible member can besecured to a support.

[0076] Those having ordinary skill in the art will know, or be able toascertain, using no more than routine experimentation, many equivalentsto the specific embodiments of the invention described herein. These andall other equivalents are intended to be encompassed by the followingclaims. All publications and references cited herein including those inthe background section are expressly incorporated herein by reference intheir entirety.

What is claimed is:
 1. A medical instrument effective to assist inpositioning an internal organ during a surgical procedure, comprising: abody; a tissue grasping element appended to the body and having at leastone tissue penetrating claw selectively movable between an open positionand a closed position; an actuating member mated to the body andeffective to move the tissue grasping element between the open andclosed positions; and a flexible member having a portion secured to thebody and at least one free end that is selectively fastenable to asupport.
 2. The medical instrument of claim 1, wherein the tissuegrasping element comprises first and second opposed tissue penetratingclaws.
 3. The medical instrument of claim 2, wherein the actuatingmember comprises opposed first and second members wherein a forceapplied to bring the first and second members in contact with each othercauses opening of the tissue penetrating claws.
 4. The medicalinstrument of claim 3, wherein the first and second tissue penetratingclaws are biased to the closed position.
 5. The medical instrument ofclaim 2, wherein the tissue grasping element forms substantially acircular shape in the closed position.
 6. The medical instrument ofclaim 2, wherein the flexible member is selected from the groupconsisting of a strap, a band, a tape, and a string.
 7. The medicalinstrument of claim 1, wherein the body is elongate and the devicefurther comprises a removable applicator sleeve slidably disposed on thebody and adapted to selectively engage the actuating member.
 8. Themedical instrument of claim 7, wherein the applicator sleeve is movablebetween a first, proximal position in which the applicator sleeve isfree from contact with the actuating member, and a second, distalposition in which the applicator sleeve is able to engage the actuatingmember and thereby move the tissue grasping element between the open andclosed positions.
 9. The medical instrument of claim 8, wherein thetissue grasping element is disposed on the distal end of the body. 10.The medical instrument of claim 9, wherein the tissue grasping elementcomprises first and second opposed tissue penetrating claws.
 11. Themedical instrument of claim 10, wherein the first and second tissuepenetrating claw are biased to the closed position.
 12. The medicalinstrument of claim 11, wherein the actuating member comprises first andsecond opposed detents.
 13. The medical instrument of claim 8, whereinat least a portion of the applicator sleeve defines an inner lumen. 14.The medical instrument of claim 13, wherein the inner lumen is adaptedto receive at least a portion of the flexible member.
 15. The medicalinstrument of claim 14, wherein the flexible member is selected from thegroup consisting of a strap, a band, a tape, and a string.
 16. Themedical instrument of claim 1, wherein the support comprises a handlemated to the free end of the flexible member.
 17. The medical instrumentof claim 16, wherein the actuating member comprises a wire slidablycommunicating between a portion of the handle and the tissue graspingelement.
 18. The medical instrument of claim 17, further comprising alever movably disposed on the handle and attached to the wire, the levereffective to move the wire and thereby move the tissue grasping elementbetween the open and closed positions.
 19. The medical instrument ofclaim 18, wherein the tissue grasping element is biased to the openposition.
 20. The medical instrument of claim 19, further comprising alatch disposed on the handle and mated to the lever for releasablylocking the tissue grasping element in one of the open or closedpositions.
 21. The medical instrument of claim 18, wherein the body issubstantially disk-shaped.
 22. The medical instrument of claim 21,wherein the body defines an inner lumen.
 23. The medical instrument ofclaim 21, wherein the tissue grasping element is fully disposed withinthe inner lumen of the body in the open position.
 24. The medicalinstrument of claim 1, wherein the body and the flexible member areintegral and comprise an elongate, rigid member having a proximal endand a distal end.
 25. The medical instrument of claim 24, wherein thetissue grasping element is selectively extendable from the distal end ofthe body.
 26. The medical instrument of claim 25, further comprising alever movably disposed on the body.
 27. The medical instrument of claim26, wherein the actuating member is a cable slidably disposed within thebody and connected between the tissue grasping element and the lever,such that movement of the lever is effective to move the tissue graspingelement between the open and closed positions.
 28. The medicalinstrument of claim 27, wherein the tissue grasping element issubstantially disk-shaped and defines a tissue piercing portion.
 29. Themedical instrument of claim 28, further comprising a gear assemblyrotatably mated to the cable and the tissue grasping element for movingthe tissue grasping element with respect to the cable.
 30. The medicalinstrument of claim 29, further comprising a biasing element mated tothe lever effective to bias the tissue grasping element to one of theopen or closed positions.
 31. The medical instrument of claim 29,further comprising a biasing element mated to the tissue graspingelement effective to bias the tissue grasping element to one of the openor closed positions.
 32. A medical instrument effective to assist inpositioning an internal organ during a surgical procedure, comprising: abody; a tissue grasping element operatively disposed within the body andhaving at least one tissue penetrating claw selectively movable betweena retracted position and an extended, tissue grasping position; aflexible member having a first end and a second end, the first endsecured to the body; a handle mated to the second end of the flexiblemember; an actuating member slidably communicating between a portion ofthe handle and the tissue grasping element effective to move the tissuegrasping element between the retracted and extended positions; and alever movably disposed on the handle and attached to the actuatingmember, the lever effective to move the actuating member and therebymove the tissue grasping element between the retracted and extendedpositions.
 33. The medical instrument of claim 32, wherein the tissuegrasping element is biased to the retracted position.
 34. The medicalinstrument of claim 33, further comprising a latch disposed on thehandle and selectively engageable with the lever for releasably lockingthe tissue grasping element in one of the retracted or extendedpositions.
 35. The medical instrument of claim 32, wherein the body issubstantially disk-shaped.
 36. The medical instrument of claim 32,wherein the body defines an inner lumen.
 37. A method for positioning abody organ, comprising: providing a medical instrument having a body, atissue grasping element appended to the body and having at least onetissue penetrating claw selectively movable between an open position anda closed position, an actuating member mated to the body and effectiveto move the tissue grasping element between the open and closedpositions, and a flexible member having a portion secured to the bodyand at least one free end that is selectively fastenable to a support;positioning the body in proximity to an internal organ to berepositioned; manipulating the body so that the tissue grasping elementgrasps a desired portion of tissue; and applying tension to the flexiblemember to reposition and secure the body organ.